search
Back to results

Pre-Visit Positive Imagery in Reducing Dental Anxiety

Primary Purpose

Dental Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Previsit Imagery Picturebook
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dental Anxiety

Eligibility Criteria

4 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients that are healthy with no systemic conditions and are considered ASA I or ASA II Patients who have never had any form of dental treatment before. Patients who need at least 1 filling to be restored with composite due to caries and will need local anesthetic and nitrous oxide inhalation. English speaking patients Exclusion Criteria: Patients with a visual impairment Patients with developmental delays that are unable to read or interpret pictures for their age-level. Patients whose treatment changes to something other than composite Patients who refuse to wear nitrous hood. Patients who are unable to read and comprehend English.

Sites / Locations

  • Herman Ostrow School of Dentistry of USCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Previsit Imagery Group

Arm Description

No intervention will be given to this group. Each treatment visit will move forward as routine.

This group will be given previsit imagery (picture book) before treatment visit.

Outcomes

Primary Outcome Measures

Dental Anxiety
Patients will also be asked to fill out a pre- and post-survey that allows them to express their level of dental fear and anxiety before and after the appointment using the Venham Picture Test. The total time commitment will be about 20 minutes and will be a part of their normal dental visit, no additional time is needed.
Patient Behavior
Parents/caregivers will also be given a post-operative survey asking whether they felt the pre-visit positive imagery helped improve patient's behavior.

Secondary Outcome Measures

Full Information

First Posted
September 15, 2023
Last Updated
September 21, 2023
Sponsor
University of Southern California
search

1. Study Identification

Unique Protocol Identification Number
NCT06058533
Brief Title
Pre-Visit Positive Imagery in Reducing Dental Anxiety
Official Title
The Effectiveness of Pre-Visit Positive Imagery in Reducing Dental Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2, 2023 (Anticipated)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether pre-visit positive imagery has an impact in decreasing dental anxiety and fear in pediatric patients as well as increasing patient cooperation during treatment visits. Patients needing at least 1 composite filling with nitrous and local anesthetic will receive a picture book if they are selected in the experimental group, and no picture book if they are in the control group. Patients will be asked to be fill out a pre-operative survey and post-operative survey asking how they feel about treatment. Parents will also be asked to fill out a post-operative survey.
Detailed Description
This study is a prospective randomized control trial. The study will be conducted at the Herman Ostrow School of Dentistry Pediatric Dental Clinic and Healthy Smiles for Kids of Orange County clinic. Established patients of record that are 4-6 years old who meet the inclusion criteria will qualify. Participants will be randomly assigned to two groups by flipping a coin and having pre-assigned envelopes in numeric order for each participant. The envelopes will be made ahead of time with heads representing Group 1 and tails representing Group 2. The envelopes will then be numbered and stored in a folder; once a participant consents to enroll in the study, the envelope will be drawn in numeric order determining the participants group number to ensure it is randomized, Group 1 will include patients receiving positive pre-visit imagery. Group 2 will be the control group and will not receive any form of positive pre-visit imagery. The positive pre-visit imagery group 1 will receive a picture book explaining their dental treatment appointment with pictures and some words. The picture book will be a hard copy and will be shown to them by a faculty advisor at USC and by the PI at Healthy Smiles for Kids. The patient's behavior will initially be assessed at their new patient or recall appointment based off the Frankl behavior scale. At the end of the treatment visit, patient behavior will be measured by the dental provider using the Frankl behavior scale. The dentists rating the behavior will be calibrated to ensure there is consistency in the Frankl scale rating and criteria for each score. Patients will also be asked to fill out a pre- and post-survey that allows them to express their level of dental fear and anxiety before and after the appointment using the Venham Picture Test. The total time commitment will be about 20 minutes and will be a part of their normal dental visit, no additional time is needed. Parents/caregivers will also be given a post-operative survey asking whether they felt the pre-visit positive imagery helped improve patient's behavior.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Anxiety

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No intervention will be given to this group. Each treatment visit will move forward as routine.
Arm Title
Previsit Imagery Group
Arm Type
Experimental
Arm Description
This group will be given previsit imagery (picture book) before treatment visit.
Intervention Type
Other
Intervention Name(s)
Previsit Imagery Picturebook
Intervention Description
This picturebook will include pictures of the dental operatory and materials the patient can expect to see during their dental treatment appointment. The pictures included will be generalized pictures of a dental operatory and dental materials. The picture book will also include some words to describe what is happening during the appointment. It is important to note that pictures of the local anesthetic / needle will not be shown in the picture book but will be used during the appointment. The procedures described are standard protocol at both clinics. The traditional picture book shown will be a hard copy.
Primary Outcome Measure Information:
Title
Dental Anxiety
Description
Patients will also be asked to fill out a pre- and post-survey that allows them to express their level of dental fear and anxiety before and after the appointment using the Venham Picture Test. The total time commitment will be about 20 minutes and will be a part of their normal dental visit, no additional time is needed.
Time Frame
1 day (1 hour during their dental visit)
Title
Patient Behavior
Description
Parents/caregivers will also be given a post-operative survey asking whether they felt the pre-visit positive imagery helped improve patient's behavior.
Time Frame
1 day (1 hour during their dental visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients that are healthy with no systemic conditions and are considered ASA I or ASA II Patients who have never had any form of dental treatment before. Patients who need at least 1 filling to be restored with composite due to caries and will need local anesthetic and nitrous oxide inhalation. English speaking patients Exclusion Criteria: Patients with a visual impairment Patients with developmental delays that are unable to read or interpret pictures for their age-level. Patients whose treatment changes to something other than composite Patients who refuse to wear nitrous hood. Patients who are unable to read and comprehend English.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Pham, DDS, MPH
Phone
4085807689
Email
cmpham@usc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Arusha Bhatia
Email
arushabh@usc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arusha Bhatia
Organizational Affiliation
Herman Ostrow School of Dentistry of USC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herman Ostrow School of Dentistry of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Pham, DDS, MPH
Phone
408-580-7689
Email
cmpham@usc.edu
First Name & Middle Initial & Last Name & Degree
Arusha Bhatia, DMD
Email
arushabh@usc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pre-Visit Positive Imagery in Reducing Dental Anxiety

We'll reach out to this number within 24 hrs